Self-selected or Predetermined Internet-based Treatment for Generalized Anxiety Disorder With Different Types of Support

February 18, 2021 updated by: Gerhard Andersson, Linkoeping University

Self-selected or Predetermined Internet-based Cognitive Behavior Therapy for Generalized Anxiety Disorder With Weekly Support or Support on Demand: A Factorial Treatment Study

This study evaluates two types of internet-based treatments for generalized anxiety disorder and two types of support. The treatments are a predetermined program for generalized anxiety disorder and a self-selected treatment. The different types of support are either a weekly contact trough a secure message system or support on demand.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Generalized anxiety disorder (GAD) is characterize by and excessive and uncontrollable worry that is present more days than not. The disorder is best described as a chronic condition with periods with more or less symptoms. The disorder is highly disabling with low quality of life for the individual and is associated with and high costs for society. Previous studies on internet-based cognitive behavior therapy for GAD has shown positive effects but there are still room for improvement.

The aim of this study is to evaluate two different internet-based treatments as well as two types of support through the use of a factorial design. The participants will be recruited trough advertising. After registration on the study's website the potential participants will be asked to answer screening questionnaires and demographic data for an initial screening. Those meeting inclusion criteria will be contacted for a diagnostic interview based Mini-International Neuropsychiatric Interview (M.I.N.I.). If meeting the study's inclusion criteria and not the exclusion criteria the participant will be included in the study and randomized to one of the four arms. The four arms are: Predetermined treatment program with weekly support, Predetermined treatment program with support on demand, Self-selected treatment with weekly support, Self-selected treatment with support on demand.

The predetermined treatment program is designed for treatment of worry and generalized anxiety disorder. It is based on newer forms of cognitive behavior therapy and includes mindfulness and acceptance. In the self-selected treatment the participants will select treatment interventions with the help of a manual and encouraged to choose interventions that they feel address their specific problems. The interventions that will be available are all based on standard cognitive behavior therapy techniques. The weekly support will be scheduled and delivered by clinical psychology students under supervision. This contact will be based on reports from the participants on the weeks work with the program and exercises. The support on demand will be also be delivered by clinical psychology students under supervision. This support takes place if and when the participant ask for support. Treatment will be 8 weeks long and both treatments will be delivered through the same platform. Contact with the participants will be trough written messages on a secure platform.

After the eight weeks of treatment the participants will be asked to answer the same measures as before the treatment as well as questions regarding how they experience the treatment. Follow up data will be collected at later points.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
85

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Östergötland
      • Linköping, Östergötland, Sweden, 58183
        • Linköpings Universitet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 18 years old
  • fulfilling criteria for generalized anxiety syndrome
  • 45 points or more on PSWQ
  • Able to read and write in Swedish
  • Have daily access to a computer and internet

Exclusion Criteria:

  • Alcohol or substance abuse
  • Acute suicidal
  • Ongoing psychological treatment
  • Ongoing medication for anxiety or depression that is planned to be adjusted during the time of the treatment given in the study
  • Complex psychiatric illness that highly disabling

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Fixed treatment, weekly support
Receives a predetermined treatment program and have weekly support.
Behavioral: Predetermined treatment
The participants will be given a treatment program designed to address worry and generalized anxiety disorder. The program are based on newer forms of cognitive behavior therapy and include mindfulness and acceptance.
Behavioral: Weekly support
The participants will have scheduled weekly support, once a week, during the treatment. The support till be delivered by students in clinical psychology.
Experimental: Fixed treatment, support on demand
Receives a predetermined treatment program and have access to support on demand.
Behavioral: Predetermined treatment
The participants will be given a treatment program designed to address worry and generalized anxiety disorder. The program are based on newer forms of cognitive behavior therapy and include mindfulness and acceptance.
Behavioral: Support on demand
The participants will have support if and when they ask for it by themselves. If asked for the support will be delivered by students in clinical psychology.
Experimental: Selected treatment, weekly support
Select their own treatment material and have weekly support.
Behavioral: Weekly support
The participants will have scheduled weekly support, once a week, during the treatment. The support till be delivered by students in clinical psychology.
Behavioral: Self-selected treatment
The participants will select their own treatment material with the help of a written manual. The interventions possible to choose are all interventions used in standard cognitive behavior therapy for anxiety and depression.
Experimental: Selected treatment, support on demand
Select their own treatment material and have access to support on demand.
Behavioral: Support on demand
The participants will have support if and when they ask for it by themselves. If asked for the support will be delivered by students in clinical psychology.
Behavioral: Self-selected treatment
The participants will select their own treatment material with the help of a written manual. The interventions possible to choose are all interventions used in standard cognitive behavior therapy for anxiety and depression.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Penn State Worry Questionnaire (PSWQ)
Time Frame: Baseline, 8 weeks, 24 months and 36 months after treatment
Measures symptoms severity of worry. 16 items, with score range 16-80. Higher score indicates worse symptoms
Baseline, 8 weeks, 24 months and 36 months after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Generalized Anxiety Disorder Questionnaire IV (GAD-Q-IV)
Time Frame: Baseline, 8 weeks, 24 months and 36 months after treatment
Designed to capture the criteria for generalized anxiety disorder according to diagnostic and statistical manual of mental disorders (DSM), 9 items with score range 0-12. Higher scores indicate greater symptom severity
Baseline, 8 weeks, 24 months and 36 months after treatment
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: baseline and weekly during 8 weeks treatment. 24 months and 36 months after treatment
Screening measure for worry and anxiety symptoms. 7 items, score range 0-21. Higher scores indicate greater symptom severity
baseline and weekly during 8 weeks treatment. 24 months and 36 months after treatment
Change from baseline in Beck Anxiety Inventory (BAI)
Time Frame: Baseline, 8 weeks, 24 months and 36 months after treatment
Measure of anxiety symptoms. 21 items with score range 0-63. Higher scores indicate greater symptom severity
Baseline, 8 weeks, 24 months and 36 months after treatment
Change from baseline in Patient Health Questionnaire (PHQ-9)
Time Frame: baseline and weekly during 8 weeks treatment. 24 months and 36 months after treatment
Screening measure for depressive symptoms. 9 items with score range 0-27. Higher scores indicate greater symptom severity
baseline and weekly during 8 weeks treatment. 24 months and 36 months after treatment
Beck Depression II Inventory (BDI-II)
Time Frame: Baseline, 8 weeks, 24 months and 36 months after treatment
Measure of severity of depressive symptoms. 21 items with score range 0-63. Higher scores indicate greater symptom severity
Baseline, 8 weeks, 24 months and 36 months after treatment
Acceptance and Action Questionnaire II (AAQ-II)
Time Frame: Baseline, 8 weeks, 24 months and 36 months after treatment
Measure of psychological flexibility. 7 items with score range 7-49 with higher scores indicate lower psychological flexibility
Baseline, 8 weeks, 24 months and 36 months after treatment
Brunnsviken Brief Quality of life scale (BBQ)
Time Frame: Baseline, 8 weeks, 24 months and 36 months after treatment
12 items, measures the quality of life. 12 items with score 0-96. Higher score indicate higher quality of life
Baseline, 8 weeks, 24 months and 36 months after treatment
General self-efficacy scale
Time Frame: Baseline, 8 weeks, 24 months and 36 months after treatment
Measure of percieved self-efficay. 10 items rated on a four-point Likert scale. Score range 10-40 with a higher score indicating a higher percieved self-efficacy.
Baseline, 8 weeks, 24 months and 36 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Linkoeping University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gerhard Andersson, Professor, Linkoeping University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • worry factorial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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